Conformis, Inc. 1080-676 BROACH, FEMORAL, ACTERA, SIZE 01

Apollo arcc® is a Health Information System facilitating the combination of patient information received from another information system (HL7 interface) with clinical multimedia (images, video, audio and other formats) and clinical information in a highly organized and secure environment. Patient information may also be entered directly into arcc. The workflow is representative of standard clinical specialties including but not limited to pathology, gastroenterology, dermatology, surgery, etc. Digital media can be imported via TCP/IP or via digital capture through direct connection to a modality device (Ex. would be a microscope mounted camera).

The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.

Stoggles square clear standard (with blue blocking + anti-fog)

The NeoCoil 3.OT 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries andassociated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout.

ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriaticagent) with different outline colors.

Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.

The device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye.

Kit. Including four scar management dressings, reusable.

Satisfaite vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Satisfaite is intended for ongoing use, not exclusively for use during intimate sexual activity. Satisfaite contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information.

Discontinued - No longer in use.

Apollo arcc® is a Health Information System facilitating the combination of patient information received from another information system (HL7 interface) with clinical multimedia (images, video, audio and other formats) and clinical information in a highly organized and secure environment. Patient information may also be entered directly into arcc. The workflow is representative of standard clinical specialties including but not limited to pathology, gastroenterology, dermatology, surgery, etc. Digital media can be imported via TCP/IP or via digital capture through direct connection to a modality device (Ex. would be a microscope mounted camera).

The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.

Stoggles square clear standard (with blue blocking + anti-fog)

The NeoCoil 3.OT 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries andassociated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout.